To read the testimony of all of but one (and a half) of the witnesses who presented before the Senate HELP committee, you can't help wonder whether the object was to pay homage to the dreadful IOM report or ignore the connection between science and FDA reform. Witnesses -- with the exception of Greg Simon's Faster Cures and the head of Benefit and Risk analysis at J and J were literally tripping over themselves talking about how important it was to spend all this money on making sure each and every drug was equally safe. Only Greg and the J and J guy managed to point out that embedding bean counters and epidemiologists from the Office of Drug Safety and giving them authority over drug appovals and study designs might add to the cost and time of new drug approvals without regard to the relative benefits of medicines. And the entire discussion was disconnected from ongoing efforts by the FDA to make pre-approval a more targered path that actually focused on eliminating safety problems.
Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)
And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.
There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.
Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise....
Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)
And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.
There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.
Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise....
